A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel (AXIOMATIC-SSP)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke; Transient Ischemic Attack (TIA)

Treatments: Drug: Aspirin; Other: Placebo; Drug: Clopidogrel; Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03766581

CV010-031

Details and patient eligibility

About

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

Enrollment: 2,366 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female ≥40 years of age
• Acute Ischemic Stroke or Transient Ischemic Attack
• Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area

Exclusion criteria

• Predicted inability to swallow study medication
• Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
• Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,366 participants in 8 patient groups, including a placebo group

BMS-986177 Placebo

Placebo Comparator group

Description:

Specified Dose on Specified Days

Treatment:

Other: Placebo

Drug: Clopidogrel

Drug: Aspirin

Dose 1: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin

Dose 2: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin

Dose 3: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin

Dose 4: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin

Dose 5: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin

Dose 6: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin

Dose 7: BMS-986177 + Aspirin + Clopidogrel

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Clopidogrel

Drug: BMS-986177

Drug: Aspirin